Comparing the effects of a triple therapy and dual bronchodilators on COPD patients
The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
This study is testing whether a new combination treatment for COPD that includes three medications works better than a treatment with just two medications to help patients breathe easier.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkoknoi, BKK) |
| Trial ID | NCT06474039 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of a combination therapy involving fluticasone furoate, vilanterol, and umeclidinium against a dual bronchodilator treatment in patients with Chronic Obstructive Pulmonary Disease (COPD). It focuses on measuring improvements in air trapping and levels of inflammatory cytokines in the blood and airways. Patients eligible for the study must have experienced limited exacerbations and have been previously treated with specific bronchodilators. The study aims to provide insights into the benefits of triple therapy compared to dual therapy in managing COPD symptoms.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with COPD GOLD B who have had no more than one exacerbation in the past year and have previously received bronchodilator treatments.
Not a fit: Patients with active pulmonary diseases, malignancies, or those currently on triple therapy or immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for COPD patients, enhancing their lung function and reducing inflammation.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in COPD management, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have met the criteria for COPD GOLD B defined by an exacerbation not more than 1 time in the last year prior to the study enrollment. These patients will be recruited in sequential sequence. * Patients with COPD GOLD B are previously treated with either LAMA or LAMA/LABA or short-acting bronchodilators * Patients who are able to provide informed consent. Exclusion Criteria: * \- Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung, other malignancy, active heart diseases. * Receiving long-term treatment with immunosuppressive drugs and systemic corticosteroids * Being treated with triple therapy (ICS/LABA/LAMA) * Being in terminally ill conditions
Where this trial is running
Bangkoknoi, BKK
- Division of Respiratory Disease and TB, Siriraj Hospital — Bangkoknoi, Bkk, Thailand (Recruiting)
Study contacts
- Principal investigator: Kittipong Maneechotesuwan, MD,PhD — Siriraj Hospital
- Study coordinator: kittipong maneechotesuwan, MD, PhD.
- Email: kittipong.man@mahidol.ac.th
- Phone: 0894996858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.